510(k) Report

FDA applicant

Euromi S.A

Shelton, CT2 decisions2001–20100 recalls

FDA records 2 decisions for Euromi S.A (Shelton, CT) from 2001 to 2010: 2 510(k) clearances. All are in product code QPB (System, Suction, Lipoplasty For Removal). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Euromi S.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Euromi S.A by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QPBSystem, Suction, Lipoplasty For Removal2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K010311Lipomatic; Lipomatic Liposuction DeviceEuromi S.A · 20011cites it

What has FDA decided for it lately?

  • K101413Euromi Eva SP6Euromi S.A · 2010
  • K010311Lipomatic; Lipomatic Liposuction DeviceEuromi S.A · 2001

All 2 as Euromi S.A →